BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS SAMPLE PREP ASSISTANT III

    MDR report key: 11627684 · Received April 7, 2021

    Report

    Report Number
    2916837-2021-00156
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 13, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    PER
    UDI-DI
    00382906472052
    PMA / PMN Number
    K131301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH TOWER OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13MAR2020 TO DATE 13MAR2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 5 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13MAR2020 TO DATE 13MAR2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE LEAK WAS COMING FROM THE WASH TOWER BECAUSE THE WASTE LINE WAS BACKED UP FROM BLOCKAGE IN THE WASTE PUMP HEAD ASSEMBLY. THE LEAK WAS WASTE AND FLUIDS USED FOR THE INSTRUMENT OPERATIONS SUCH AS SHEATH, DI WATER AND LYSE. THERE WAS NO BODILY CONTACT OR HARM TO THE CUSTOMER OR FSE CAUSED BY THE LEAK HOWEVER THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. BLEACH WAS USED TO CLEAN AND DISINFECT THE INSTRUMENT AND SURROUNDING AREAS. THE CLOG IN THE WASTE PUMP HEAD WAS DUE TO CORES FROM THE YELLOW VACUTAINER CAPS. THE TUBES USED ARE BD VACUTAINER ACD SOLUTION A #364606. THE PROBE HAD 123 PIERCINGS AND WAS LOT# F164970. THE BLOCKAGE WAS CLEARED AFTER DISASSEMBLING THE HEAD AND FLUSHING WITH DI WATER. THE PUMP WAS RE-ASSEMBLED, AND THE COUPLINGS WERE REPLACED TO AVOID ANY FURTHER CORES FROM GOING DOWNSTREAM PAST THE FILTER. THE FILTER WAS INSPECTED. THE INSTRUMENT WAS TESTED AND VERIFIED AS OPERATING TO SPECS. THE PROBLEM WAS CORRECTED AND THERE WAS NO FURTHER LEAKING OR BLOCKAGE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER # (B)(4). INSTALL DATE: (B)(6) 2009. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: WASH TOWER OVERFLOWING. PROBLEM DESCRIPTION: FLUIDICS. CAUSE: CLOGGED WASTE PUMP AND FLUIDIC LINES. WORK PERFORMED: CLEARED FLUIDIC LINES AND CLEANED OUT PUMP. SOLUTION: CLEARED FLUIDIC LINES AND CLEANED OUT PUMP. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 100245RA, REVISION 02 WAS REVIEWED. HAZARD ID: 3.1.29. HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. RISK CONTROL: ALARP. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED PUMP AND FLUIDIC LINE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH TOWER OVERFLOWING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH STATION OVERFLOW. THE LEAK WAS COMING FROM THE WASH TOWER BECAUSE THE WASTE LINE WAS BACKED UP FROM BLOCKAGE IN THE WASTE PUMP HEAD ASSEMBLY. THE LEAK WAS WASTE AND FLUIDS USED FOR THE INSTRUMENT OPERATIONS SUCH AS SHEATH, DI WATER AND LYSE. THERE WAS NO BODILY CONTACT OR HARM TO THE CUSTOMER OR FSE CAUSED BY THE LEAK HOWEVER THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. BLEACH WAS USED TO CLEAN AND DISINFECT THE INSTRUMENT AND SURROUNDING AREAS. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: WASH STATION OVERFLOW. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THEY HAVE CLEANED THE FILTERS BUT THIS HAS NOT HELPED. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? YES. RESOLUTION ACHIEVED (Y/N)? NO.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH STATION OVERFLOW. THE LEAK WAS COMING FROM THE WASH TOWER BECAUSE THE WASTE LINE WAS BACKED UP FROM BLOCKAGE IN THE WASTE PUMP HEAD ASSEMBLY. THE LEAK WAS WASTE AND FLUIDS USED FOR THE INSTRUMENT OPERATIONS SUCH AS SHEATH, DI WATER AND LYSE. THERE WAS NO BODILY CONTACT OR HARM TO THE CUSTOMER OR FSE CAUSED BY THE LEAK HOWEVER THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. BLEACH WAS USED TO CLEAN AND DISINFECT THE INSTRUMENT AND SURROUNDING AREAS. IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: WASH STATION OVERFLOW. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THEY HAVE CLEANED THE FILTERS BUT THIS HAS NOT HELPED. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? N. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? Y. RESOLUTION ACHIEVED (Y/N)? N.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523577 BD FACS SAMPLE PREP ASSISTANT III SEE H.10 PER BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 647205 NA 00382906472052

    Patients

    Seq Age Sex Outcome Treatment
    1